A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/3/2016 |
Start Date: | April 2012 |
End Date: | September 2015 |
A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (Metmab) in Combination With Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients With Stage IIIb (T4 Disease) or IV Squamous Non-Small Cell Lung Cancer (NSCLC)
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the
efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in
patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC).
Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on
Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and
platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not
progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as
maintenance therapy until disease progression or unacceptable toxicity occurs.
efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in
patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC).
Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on
Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and
platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not
progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as
maintenance therapy until disease progression or unacceptable toxicity occurs.
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small
cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- No prior chemotherapy for squamous NSCLC
- Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR
status is unknown
- Radiographic evidence of disease
Exclusion Criteria:
- Prior systemic treatment for Stage IIIB or IV squamous NSCLC
- NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous,
or NSCLC not otherwise specified (NOS)
- Prior exposure to experimental treatment targeting either the HGF or Met pathway
- Patients with tumors confirmed to have EGFR-activating mutations who are suitable for
anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator
- Uncontrolled brain metastases and treatment by neurosurgical resection or brain
biopsy within 4 weeks prior to Day 1 of Cycle 1
- History of another malignancy in the previous 3 years except for prior history of in
situ cancer or basal or squamous cell skin cancer
- Pregnant or lactating women
- Uncontrolled diabetes
- Impaired bone marrow, liver or renal function as defined by protocol
- Significant history of cardiovascular disease
- Positive for HIV infection
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